Category: Featured

WHO Likely to Reject Medicago Covid Vaccine
The World Health Organization is unlikely to grant emergency approval Medicago’s tobacco plant-based Covid-19 vaccine due to the company’s ties to the tobacco industry, the CBC reported on March 17.
The global health body has reportedly paused the process for pre-qualification of Medicago’s new Covifenz shot due to its link to Philip Morris International, which owns about one-third of the Canadian biopharmaceutical company.
“Due to its connections [to PMI], the process is put on hold,” said Mariangela Simao, the WHO’s assistant director-general for drug access, vaccines and pharmaceuticals, at a March 16 media briefing.
“The WHO and the U.N. have a very strict policy regarding engagement with the tobacco and arms [industries], so it’s very likely it won’t be accepted for emergency use listing,” she said.
In February, Health Canada approved Covifenz for adults 18 to 64 years of age, making it the world’s first vaccine approved for human use that utilizes a plant-based protein technology. The Canadian government floated CAD173 million ($136.74 million) to help the company develop the jab and is so far the only country to approve it.
In October 2020, Canada signed a deal to buy 76 million doses of Medicago’s vaccine, and the shot is expected to be made available to the public in May.
In a statement published by the CBC, Medicago said it believes authorization decisions should be based on the quality, efficiency and safety of the vaccine, not who owns shares in the manufacturer.
“It is our understanding that the WHO has made a decision to pause the approval of the vaccine and that this decision is related to Medicago’s minority shareholder and not to the efficacy and safety of the vaccine, which was demonstrated with the approval by Health Canada,” the statement reads.
Derek Yach, a global health consultant, was aghast by the WHO’s suggestion that it would reject Medicago’s vaccine based on the company’s relationship with PMI.
“‘Pikuach nefesh’ is the ethical principle in Jewish law that the preservation of human life overrides virtually any other religious rule,” he said. “Most other religions support a variant of this. WHO violates this ethical principle when it denies people access to a lifesaving vaccine.”
If the WHO follows through, the vaccine would be the first Western-manufactured Covid-19 shot to be rejected by the global health body, according to Bloomberg.
March 17, 2022
Sneak Peek at New Vapor Rules in China

Photo: Kajsym Yemelyanov
Starting May 1, China will begin enforcing the licensing rules for e-cigarette production, wholesale and retail entities. The new rules, the draft of which was first announced in December 2021, apply to all hardware and e-liquid products, including all components and ingredients.
“The administrative department in charge of tobacco monopoly of the State Council takes charge of national supervision and management of electronic cigarettes, and is responsible for the formulation and organization of implementing electronic cigarette industry policies,” the regulations state. “The administrative department in charge of tobacco monopoly of the State Council shall organize professional institutions for technical review of electronic cigarette products based on inspection and testing reports and other application materials.
“Electronic cigarette products not sold in China and only used for export shall comply with the laws, regulations and standards of the destination country or region,” the rules state. “If the destination country or region does not have relevant laws, regulations and standards, they shall comply with China’s relevant laws, regulations and standards.”
Critically the new rules also ban nontobacco flavors and the sale of open systems. The importation of any vaping related products, such as pre-mixed e-liquids, must also be approved by Chinese authorities, according to the regulations.
Any company that produces e-cigarettes in China must now get a license. If a company wants to expand its production or product portfolio, the company must garner approval from the State Tobacco Monopoly Administration. All nicotine must be tobacco derived and purchased from approved sellers in China. Chinese regulators will also establish a comprehensive e-cigarette traceability system to keep track of vaping products.
“Electronic cigarette wholesale enterprises shall not provide electronic cigarette products to units or individuals that are not qualified to engage in electronic cigarette retail businesses,” the regulation states.
The rules also specify that “enterprises or individuals that have obtained the tobacco monopoly retail license … shall purchase electronic cigarette products from local … wholesale enterprises, and shall not exclusively operate the electronic cigarette products sold on the market.”
According to an industry expert, this means all retail outlets must sell multiple brands and not just a single brand. Traditionally, companies such as RELX only sold their own brands in their stores.
Additionally, authorities will establish a “unified national electronic cigarette transaction management platform” that e-cigarette industry businesses that have obtained tobacco monopoly licenses must conduct all transactions through.
The rules also encourage stakeholders to report illegal activity. “Rewards will be given to units and individuals who have made meritorious deeds in reporting cases of illegal production and sales of electronic cigarette products, e-atomization material products and electronic cigarette nicotine,” the rules state.–T.S.D.
March 16, 2022
FDA Gets Authority Over Synthetic Nicotine

Photo: The White House
U.S. President Joe Biden on Tuesday signed into law a spending bill that gives the Food and Drug Administration authority over synthetic nicotine.
The language of the Tobacco Control Act will now change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”
The amendment comes into effect 30 days after the bill’s enactment. Manufacturers of products made with synthetic nicotine will then have an additional 30 days to submit a premarket tobacco product application (PMTA) to the FDA. If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market.
According to Bryan Haynes, a partner with Troutman Pepper, the measure could amount to an effective ban on synthetic nicotine products. “FDA is highly unlikely to authorize a PMTA in 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years,” he wrote on the law firm’s blog.
April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA) suspects the bill will have little effect on youth vaping, which is already down significantly since highs in 2015. “Although the sponsors of the bill claim the intent was to close the loophole on synthetic nicotine-derived products from large companies now popular among youth, the reality is that this bill—and others like it—aren’t likely to have the intended effect,” she said. “Instead, consumers using these products as a harm reduction option will suffer, as will licensed small businesses in full compliance with federal, state, and local laws.
“The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, grey and black markets emerge where there are no regulations requiring safe products or ID checks.”
The FDA appears keen to crack down on synthetic nicotine. During his Senate confirmation hearing, FDA Commissioner Robert Califf vowed to close what he described as the synthetic nicotine “loophole.”
March 16, 2022
Scientists Debunk Vaping Gateway Theory

Photo: Richard Johnson
A study published by the scientific journal Addiction has found that prevalence of e-cigarette use in England among young adults between 2007 and 2018 did not appear to be associated with substantial increases or decreases in the prevalence of smoking uptake.
Several longitudinal observational studies have previously pointed towards a possible gateway effect between initiation of e-cigarettes and later use of cigarettes in adolescents. However, these findings may reflect shared vulnerability such that the same young people who would try e-cigarettes would also more likely later to smoke cigarettes.
One way to avoid this self-selection bias is to assess the impact at the population level rather than the individual level, using an approach called time series analysis. Using this method, the current study measured the gateway effect of vaping by looking at the association between prevalence of e-cigarette use among young adults and prevalence of uptake of smoking generally, including among people who have never smoked. The researchers reasoned that if a gateway effect existed, there ought to be associated population-wide changes in the prevalence of smoking uptake when the prevalence of vaping changed. Conversely, if a gateway effect did not exist, changes in e-cigarette prevalence should not be associated with changes in uptake of smoking among young adults.
The authors found no statistically significant association between the prevalence of e-cigarette use and ever having smoked regularly (used as an indicator of uptake) among those aged 16 to 24. To interpret this finding further, the authors used Bayes factors and robustness regions. Bayes factors help interpret whether a non-significant finding is evidence of no difference or whether the study was not sensitive enough to detect an effect. Robustness regions identify the size of effect which can be plausibly dismissed. The authors were able to rule out a gateway effect from e-cigarette use to smoking uptake of the size commonly reported in the literature but were not able to rule out very small effects for a gateway in or out of smoking (where e-cigarette use makes it less likely that young people start to smoke).
“These findings suggest that the large gateway effects reported in previous studies can be ruled out, particularly among those aged 18 to 24,” said lead author Emma Beard. “However, we cannot rule out a smaller gateway effect and we did not study younger age groups. If the upper estimates are true, we would estimate that of the 74 thousand e-cigarette users aged 16 to 17 in England, around 7,000 would become ever regular smokers as a consequence of e-cigarette use. At the same time, approximately 50 thousand smokers are estimated to quit per year as a consequence of e-cigarette use.”.
“These findings are important given the contrasting advice given by health bodies and governments in different countries,” said senior author Lion Shahab. “Research to date supports the argument that e-cigarettes are less harmful than tobacco and help smokers to stop smoking. Although some harm from vaping relative to never vaping cannot be ruled out, this study suggests there is little evidence of a substantial gateway effect into smoking.”
March 16, 2022
Vaping Advocates Launch ‘Best Practices’ Series

Tobacco harm reduction (THR) advocates will come together over the next two months to brainstorm, download and debate the best ways to advance safer nicotine products globally.
Nancy Loucas
“Advocates from around the world have been asking for seminars on the nuts and bolts of advocacy, what is effective, where to find information and how to get the message across. This new online series will address a real need out there,” says Nancy Loucas, executive coordinator for the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA).
Dubbed the Advocates Voice Shorts Series, five sessions will be livestreamed fortnightly, launching on March 26 and finishing up on May 21.
“It’s obvious that the war on nicotine is not going away. Advocates need information and support to carry on fighting as THR is here to stay. Nearly 70 countries have already adopted regulatory frameworks on safer nicotine products, leading to dramatic declines in their overall smoking rates. If we are to save millions of more lives, our advocacy needs to be incredibly effective,” says Loucas.
Each of the five programs will start with a short video presentation followed by a live Q&A session for advocates to help each other. Those actively campaigning for adults to have access to safer nicotine products in their respective countries will discuss and detail the issues and questions they encounter.
The episodes will run via the CAPHRA and sCOPe YouTube channels at 12:00 p.m. NZT. To view the series promotion and see the links for each program, visit https://youtu.be/4H9CdRGv0zk.
“In recent years, effective advocacy has been key to many countries adopting a THR approach. Advocates coming together for this initiative and discussing best practice will be time well spent. The aim for us as always is to deliver tangible results, namely saving smokers’ lives,” says Loucas.
March 16, 2022
British Authorities Seize Illicit Tobacco

Photo: Tobacco Reporter archive
Authorities seized 13 million illegal cigarettes and 4,300 kilos of hand-rolling tobacco across England and Wales, reports City AM.
The operation involved raids on homes and shops conducted by Her Majesty’s Revenue and Customs (HMRC) staff, Border Force officials, police and local authorities. The raids are part of a broader strategy aiming to tackle the government’s “three ‘tiers’ of criminality,” with HMRC shutting down illegal factories abroad and Border Force intercepting smuggled products and cash at the border.
Illegal trade costs the treasury £2 billion ($2.61 billion) each year. The government has implemented high and increasing tobacco tax, raising duty by 2 percent above the rate of inflation each year in order to discourage consumption and raise revenue. As duties have increased, though, illegal trade has also increased.
According to the European Anti-Fraud Office, 70 percent of U.K. consumers buy black market tobacco products because they are cheaper than legal products.
March 15, 2022
Armenia Bans Smoking In Public Places

Photo: Taco Tuinstra
Armenia has banned the use of tobacco products in open spaces effective today, reports the Public Radio of Armenia.
Smoking is now prohibited in public catering establishments, including open-air ones such as canteens, restaurants, cafes, bars, cafeterias, cooking and selling facilities.
Violation risk fines ranging from AMD50,000 ($97.38) to AMD200,000.
The law aims at protecting present and future generations from the negative impact caused by the use of tobacco products.
March 15, 2022
Imperial Negotiates Transfer Russian Assets

Photo: Casimirokt | Dreamstime.com
Imperial Brands has begun negotiations with a local third party about a transfer of its Russian assets and operations.
“We believe that, in the current circumstances, an orderly transfer of our business as a going concern would be in the best interests of our Russian colleagues,” the company wrote in a press release. “We employ 1,000 people in Russia in our sales and marketing operations and in our factory in Volgograd—and their safety and well-being is our key priority in this process. We will also continue to pay their salaries until any transfer is concluded.
“Meanwhile, we are also supporting our Ukrainian colleagues and their families, including with transport and accommodation to enable them to escape the areas most severely hit by conflict as well as [with] resettlement assistance for those who have left Ukraine.
“We have evaluated the financial impact of an exit from Russia and the previously announced suspension of operations in Ukraine on our full-year guidance for FY22. We now expect full-year constant currency net revenue growth of around 0 [percent] to 1 percent. While there will be some ongoing costs related to the suspension in Ukraine, we expect a relatively small impact on our constant currency adjusted operating profit, reflecting the limited profit contribution of the two markets. In FY21, Russia and Ukraine represented in total around 2 percent of net revenues and 0.5 percent of adjusted operating profit. Any transaction relating to our Russian business is subject to agreement being reached.”
March 15, 2022
SM Pauses Separation of Cigar Business

Photo: Swedish Match
Swedish Match has suspended the separation of its cigar business until further notice.
On Sept. 14, 2021, Swedish Match announced its intention to spin off its cigar business to shareholders and subsequently list it on a U.S. national securities exchange. The separation was initially expected to be completed in the second half of 2022, at the earliest.
The decision to suspend the separation was driven by regulatory uncertainties, according to Swedish Match.
“While supply chain related challenges have contributed to the financial development of the U.S. cigar business falling short of Swedish Match’s expectations in recent quarters, today’s decision to suspend the spin-off preparations was prompted by regulatory uncertainties facing the cigar business,” the company wrote in a statement.
The U.S. Food and Drug Administration recently denied substantial equivalence (SE) designations for applications corresponding to about 3 percent of Swedish Match’s 2021 cigar volume. According to Swedish Match, it cannot be ruled out that additional SE applications for the cigar assortment will be denied in the first instance as FDA continues to work through remaining applications.
Swedish Match said it plans to appeal the non-SE designations by the FDA by requesting a supervisory review. The company remains confident that it will be given the opportunity to provide the FDA with sufficient data in order to demonstrate that the cigars in question are substantially equivalent to their predicate products insofar that the changes that have taken place do not raise questions of public health.
“Swedish Match is confident that the above-mentioned issues will be resolved or efficiently mitigated in due course,” the company wrote in its statement. “However, the board’s view is that the decision to suspend spin-off preparations until further notice is in the best interests of our shareholders. As the potential impacts from regulatory uncertainties have been clarified, the Swedish Match board expects to resume plans to separate the cigar business.”
March 15, 2022
Zimbabwe to Crack Down on Side Marketing

Photo: Taco Tuinstra
Zimbabwe’s Tobacco Industry and Marketing Board (TIMB) is cracking down on the side marketing of tobacco leaf during the 2022 selling season, according to The Sunday Mail.
“We have engaged relevant authorities to come up with a Statutory Instrument (SI) on side marketing,” said Saviour Muvirimi, TIMB head of inspectorate. “We also recruited informers in all farming areas in order to receive information on the presence of illegal buyers in communities.”
Police would be brought in to arrest those caught side marketing, according to Muvirimi. “TIMB will be making constant radar sweeps on frequency of sales on grower numbers with the view to identify grower numbers perpetuating side marketing. Respective individuals will be called to explain these sales, and if we are not convinced, we will block and suspend the grower numbers and refer such criminal elements to the Zimbabwe Republic Police for arrest.”
“Farmers who side market tobacco actually play around statistics by adjusting estimates,” he said, adding that the police department would be strict on addressing adjustment of estimates by farmers.
“TIMB will not hesitate to suspend sales and revoke licenses from contractors involved in side marketing. (We will) increase our surveillance patrols in farming communities in order to identify makorokoza’s (dealers) and errant licensed contractors engaging themselves in side marketing,” Muvirimi said.
March 15, 2022